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Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis
EU CTIS ID: 2024-515964-30-00
What this study is testing
Allow patients to continue or start AP01 therapy for the treatment of ILD and IPF until applicable regulatory approval or until the study is terminated To evaluate safety outcomes of patients while on AP01 therapy
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Prior participant in an Avalyn AP01 study, excluding normal healthy volunteers OR
- Patients with no other treatment options with ILDs, including but not limited to IPF, fibrosing phenotype ILD, pulmonary involvement of scleroderma, rheumatoid lung and silicosis. Prior Sponsor approval of non-Avalyn study rollover patients is required.
- Diagnosed chronic progressive fibrotic ILD, including IPF, without treatment alternatives such as: a. Not eligible for oral pirfenidone and nintedanib due to national formulary restrictions or lack of applicable regulatory approval b. Intolerant to oral pirfenidone and nintedanib, if previously offered c. Not eligible for an ongoing clinical study of AP01 other than this study
- Age greater than 18 years at Screening
- Able to understand and sign, prior to study entry, a written informed consent form (ICF) consistent with International Council on Harmonisation Guideline for Good Clinical Practice (ICH-GCP) and local laws
- Able to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements, including the concomitant medication restrictions, throughout the study
You likely can't join if
- Disease-Related Exclusions 1. Significant clinical worsening of ILD/IPF for AP01 naïve patients between Screening and Day 1, in the opinion of the Investigator
- Participation in a clinical study with administration of an investigational drug product within the previous 30 days, or five half-lives of the previously administered investigational product (IP) (AP01 naïve patients only)
- Hypersensitivity to the active substance or to any of the excipients of pirfenidone
- Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the Investigator
- History of acute IPF exacerbation requiring hospitalization in the last 30 days
- Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis
See the full eligibility criteria
Who can join
- Prior participant in an Avalyn AP01 study, excluding normal healthy volunteers OR
- Patients with no other treatment options with ILDs, including but not limited to IPF, fibrosing phenotype ILD, pulmonary involvement of scleroderma, rheumatoid lung and silicosis. Prior Sponsor approval of non-Avalyn study rollover patients is required.
- Diagnosed chronic progressive fibrotic ILD, including IPF, without treatment alternatives such as: a. Not eligible for oral pirfenidone and nintedanib due to national formulary restrictions or lack of applicable regulatory approval b. Intolerant to oral pirfenidone and nintedanib, if previously offered c. Not eligible for an ongoing clinical study of AP01 other than this study
- Age greater than 18 years at Screening
- Able to understand and sign, prior to study entry, a written informed consent form (ICF) consistent with International Council on Harmonisation Guideline for Good Clinical Practice (ICH-GCP) and local laws
- Able to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements, including the concomitant medication restrictions, throughout the study
- Females of childbearing potential (FOCBP) must use an effective contraceptive method during the clinical study and 30 days after the last dose of AP01 as described in Section 7.3.6, Pregnancy Testing.
What rules you out
- Disease-Related Exclusions 1. Significant clinical worsening of ILD/IPF for AP01 naïve patients between Screening and Day 1, in the opinion of the Investigator
- Participation in a clinical study with administration of an investigational drug product within the previous 30 days, or five half-lives of the previously administered investigational product (IP) (AP01 naïve patients only)
- Hypersensitivity to the active substance or to any of the excipients of pirfenidone
- Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the Investigator
- History of acute IPF exacerbation requiring hospitalization in the last 30 days
- Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis
- Medical Exclusions 5. Females with a positive pregnancy test at Screening (AP01 naïve patients) or Baseline (Rollover patients from previous study) or are currently breastfeeding
- Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 6 months. This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma)
- Any condition other than ILD/IPF that, in the opinion of the Investigator, is likely to result in the death of the patient within the next 6 months
- History of severe hepatic impairment, end-stage liver disease, or AST or ALT greater than 5 times the upper limit of normal at Screening (AP01 naïve patients)
- History of end-stage renal disease requiring dialysis
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- New Zealand
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; New Zealand; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.